Smiths Medical Recalls More Than 19 Million CADD System Administration Sets and Cassette Reservoirs Because of Medication Delivery Issues

February 07, 2023

On February 2, 2023, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-cadd-system-administration-sets-and-cassette-reservoirs-issues) Smiths Medical’s recall of its CADD™ infusion system administration sets and cassette reservoirs because of tubing occlusions that may under- or not deliver medication and false no disposable attached (NDA) alarms that may prevent pump use. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.

Smiths Medical Recalls More Than 19 Million CADD System Administration Sets and Cassette Reservoirs Because of Medication Delivery Issues

Smiths Medical received reports of 1,571 incidents, 14 injuries, and two deaths related to the tubing occlusion issue and 9,101 incidents, 11 injuries, and no deaths related to the false NDA alarm issue. The recall affects more than 19 million sets distributed since June 15, 2018. FDA lists the recalled product codes in its medical device recall database (https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-cadd-system-administration-sets-and-cassette-reservoirs-issues?utm_medium=email&utm_source=govdelivery#recalldatabase).

Smiths Medical issued the recall because of two potential problems:

The recall issues can delay or interrupt therapy or underdeliver medication, which all have the potential to cause serious patient harm or death.

The following people may be affected by the recall:

On December 9, 2022, Smiths Medical notified consumers via an urgent medical device correction letter. For both recall issues, Smiths Medical recommended using an alternative CADD infusion sets for life-sustaining medications. Consumers can contact Smiths Medical customer service at 800-258-5361 for information on obtaining alternate CADD infusion sets. 

For the tubing occlusion issue, Smiths Medical recommended that:

For the false NDA alarm issue, Smiths Medical recommended that:

To report adverse events or product complaints, contact Smiths Medical’s global complaint management at 866-216-8806 or globalcomplaints@smiths-medical.com (mailto:globalcomplaints@smiths-medical.com).

For additional information or technical assistance, contact Smiths Medical’s technical assistance at 800-258-5361. 

Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experience using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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